Needle assembly for parenteral liquid container



United States Patent [72] Inventors John N. Pagones Sunland, California;

Elmer F. St. Amand, North Hollywood, California [21] Appl. No. 685,573

[22] Filed Nov. 24, 1967 [45] Patented Aug. 11, 1970 [73] AssigneeAmerican Hospital Supply Corporation Evanston, Illinois a Corp. ofIllinois [54] NEEDLE ASSEMBLY FOR PARENTERAL LIQUID 2l4,2l4.2,215,2l6,221,272

[56] References Cited UNITED STATES PATENTS 2,674,265 4/1954 Dennisl28/213X 2,866,457 12/1958 Moore 128/214 2,955,595 10/1960 Semple128/214 20 I7 35 I6 l8 Primary Examiner Dalton L. Truluck Attorney-Larry N. Barger and Robert T. Merrick ABSTRACT: A blood bag with a donortube having a needle assembly at its distal end. This needle assemblyhas a cannula with a sharpened forward end and an enlarged tubularadapter cemented to a rear end of the cannula. A soft thermoplastichousing that is not readily bendable to the adapter includes hub andprotector sections that encase the adapter and cannula respectively. Apair of longitudinally spaced facing shoulders in the hub section abutends of the adapter to mechanically lock the adapter againstlongitudinal movement relative to the hub section. When used to make avenipuncture, the protector section is broken off from the hub sectionof the housing at a frangible peripheral groove structure, locatedforward of both shoulders in the hub section. Thus, after the protectorsection is removed to expose the sharpened end of the cannula, the rearof the cannula and adapter are still firmly anchored in the hub section.

NEEDLE ASSEMBLY FOR PARENTERAL LIQUID CONTAINER This invention relatesto an improvement in parenteral liquid containers commonly referred toas blood bags. These blood bags" normally include a flexible sac or bagwith a donor tube for filling the bag with blood from a donor, andoutlet ports for dispensing the blood to a patient. At an outer end ofthe doner tube is a needle assembly for making a venipuncture in thedonors arm. It is to such a needle assembly that this invention relates.

It is of utmost importance to maintain the sterile integrity of ahypodermic cannula used to make the venipuncture. If the cannula iscontaminated it could be dangerous to the blood donor and suchcontamination could also be washed into the blood bag and administeredto the patient. To insure that the hypodermic needle is sterilelyprotected, this invention provides in the combination of a blood bag anda flexible donor tube, a cannula with a sharpened forward end, a tubularadapter connected to a rear end of the cannula, and a onepiece plastichousing encasing the cannula and adapter. The one-piece housing is notreadily bondable to the adapter but has desired fiangible properties,and includes a hub section with longitudinally spaced shoulders abuttingends of the adapter to mechanically lock the adapter to the hub section.A frangible groove section in the housing, located forward of bothshoulders of the hub section, provides a structure for breaking apartthe hub end protector sections without destroying the mechanical lockbetween the hub section and the adapter. Immediately prior to use, thenurse checks to see if the protector section is still attached to thehub section of the housing. If the grooved section is broken, she has avisual indication that the donor needle is unsafe to use.

The donor needle assembly described above is intended to protect thecannula used to make the venipuncture in the donors arm. It has alsobeen found that a second needle assembly of the same construction can beattached to the end of a branch tube joined to the donor tube betweenthe blood bag and donor needle assembly. This second needle assembly,called a sampling needle assembly, is used for taking blood samples asblood is drawn from the donor. Such samples taken directly from thedonor tube are necessary for certain tests requiring samples of bloodwhich have not been mixed with the anticoagulant solution in the bag.

Perhaps the invention can be better understood with reference to thefollowing drawings, in which:

FIGURE 1 is a front elevational view ofthe blood bag showing both thedonor needle assembly and the sampling needle assembly attached to theflexible donor tube;

FIGURE 2 is an enlarged top plan view of the donor needle assembly;

FIGURE 3 is a sectional view taken along line 3-3 of FIGURE 2; and

FIGURE 4 is a sectional view taken along line 4-4 of FIGURE 2.

Referring in more specific detail to the drawings, FIGURE 1 shows theflexible blood bag 1 having at its top end a port structure 2 with donor(collection) tube 3 and dispensing spouts 4 and 5, which spouts havetear-off caps 6 and 7 protecting them from contamination. The bag has ahanging structure 8 at its bottom end for suspending the blood bagupside down when dispensing blood. On each side of the bag are loops 9,10, 11 and 12 for retaining small test tubes used in collecting samplesof blood from the donor tube.

The flexible donor tube 3 is integrally attached at one end to the bagand has a donor needle assembly 13 at its opposite end. The details ofthe donor needle assembly are best seen in FIGURES 2, 3 and 4. As shownin these FIGURES, the donor needle assembly includes a cannula l4sharpened at its forward end. At its rearward end the cannula has atubular adapter 15 of a rigid plastic such as Nylon cemented to thecannula. The tubular adapter has a narrowed tube-receiving section 16 atits rear which fits inside the flexible donor tube. Thus, the cannula'spassage is directly connected through the tubular adapter to the donortubes bore.

To sterilely protect the cannula and adapter is a one-piecethermoplastic housing 17 which has a hub section 18 and a protectorsection 19, respectively, fitting over the adapter and cannula. The huband protector sections are joined together by a section with aperipheral groove 20 and the housing section can be between .010 inchand .050 inch thick at the groove but is preferably about .020 inchthick.

The tubular adapter supporting the cannula is rigidly held in thehousings hub section. It is held against forward movement by anecked-down portion 21 inside the hub section near groove 20. Theadapter is held against rearward movement by the donor tube abutting anexternal flange 22 on the adapter, because the donor tube is sealed tothe inside of the hub section by a solvent seal or heat seal. Thus, thehousing and donor tube, both of plasticized polyvinyl chloride, can besealed together to amply lock in the adapter which, because it is ofnylon, cannot be readily solvent or heat sealed to the hub section ofthe housing.

Inside the protector section 19 is another feature of the invention. Asshown in FIGURE 3, the protector section has a chamber with a forwardportion 23 that is approximately the same diameter as the cannulasoutside diameter and fits tightly about the cannula. This forms aneffective seal with the forward end of the cannula and keepsanticoagulant solution within the bag from leaking out of the cannulaand filling the chamber encasing the cannula. This chamber in theprotector section also has a rear portion 24 that is larger in diameterthan the cannula to reduce frictional drag when the protector is pulledoff the cannula preparatory to inserting the cannula in the donors arm.

When a nurse is ready to take blood from a donor, she grasps the hubsection of the housing in the indented areas 25 and 26 with one hand,thus giving her firm control of the hub. With the other hand she graspsthe protector section and twists it relative to the hub section. Thelongitudinal ribs 27 and 28 on the protector section keep her fingersfrom slipping on the protector section. After the protector has beenbroken apart at groove 20 and the protector removed, she then makes thevenipuncture and begins withdrawal of the blood. Preferably, the hubsection has its bottom surface 36 slanted so the hub fits closely to thedonors arm when the cannula is in his vein. An indicator arrow 29 on topof the hub section shows the orientation of bevel 30 of the sharpenedend of the cannula even when it is hidden from view in the donors arm.After blood begins to flow from the donor, the nurse can stop it at anytime by closing clamp 31 on the donor tube.

The structure described above is sufficient for collecting blood.However, sometimes it is desirable to sample the blood from the donorbefore it gets into the bag and mixed with anticoagulant solution in thebag. Such sampling can be accomplished with the structure shown inFIGURE I. Here, a flexible branch tube 32 joins the donor tube at aY-connector 33 positioned in the donor tube between the bag and donorneedle assembly. On an outer end of the branch tube is a sampling needleassembly 34 which can have the same structure as the donor needleassembly. When an operator desires a sample, he shuts off clamp 31.Next, he breaks off the protector of the sampling needle assembly andinserts the cannula into a sample receiving test tube, usually through apuncturable rubber stopper in the test tubes mouth. When a sufficientsample has been collected, he can shut off the blood flow by closing offcollar permanently secured to the cannula adjacent its rear end and ahollow housing fitting over the collar and cannula with a hub sectionand a protector section separable along a frangile circumferentialgroove, the improvement of: a pair of longitudinally spaced shouldersboth of which are attached to the hub section and located rearwardly ofthe housings frangible circumferential groove, one of the shouldersbeing provided by an end surface of a tube bonded to the hub section ofthe housing, said retaining collar abutting said shoulders to firmlylock the collar and cannula from longitudinal movement, relative to thehub section after the protector has been removed by fracturing thehousing at the circumferential groove.

2. The improvement in a hypodermic needle and protector combination asset forth in claim 1, wherein the retaining collar and hub section areof dissimilar materials that are not readily bondable together.

3. The improvement in a hypodermic needle and protector combination asset forth in claim 1, wherein said shoulder is formed by an end portionofa flexible tube fitting within and bonded to the housings hub section,said flexible tube extending a substantial distance beyond the housingto conduct fluid to or from said cannula.

4. The improvement in a hypodermic needle and protector combination asset forth in claim 3, wherein the retaining collar and hub section areof dissimilar materials that are not readily bondable together.

5. A sterile needle assembly in combination with a flexible tube ofablood bag donor assembly or the like comprising: an elongated, rigidcannula having a sharpened forward end;

i a rigid tubular adapter circumposed about and projecting rearwardlybeyond the rear end of said cannula,

said adapter comprising a rigid plastic compatible to and being fixedlysecured over the rear end of said cannula;

said adpater having an enlarged diameter intermediate portion definingforward and rear shoulders;

at flexible tube ofa relatively soft thermoplastic material incompatibleto being sealingly connected to said adapter and being telescopicallyreceived on the rear end of said adapter and in abutting engagement withsaid adapter rear shoulder; and

a one-piece soft thermoplastic housing compatible to and being sealinglysecured to said flexible tube and incompatible to being sealinglyconnected to said adapter,

said housing including a forward, closed sleeve portion sheathing saidsharpened forward end of said cannula and integral with a rear portioncircumjacent to and surrounding said flexible tube and adapter andsealingly connected to the tube of compatible plastic material,

said rear portion of said housing including a forward internal shoulderabuttingly engaging the forward shoulder of said adapter andmechanically interlocking the adapter and cannula against axial movementrelative to the rear portion of said housing,

said housing including a reduced diameter, annular groove defining afrangible connection forwardly of the forward shoulder of said adapterand the mechanical interlock and being manually-severable to separatethe forward and 5 rear housing portions without disturbing themechanical interlock between the adapter and the rear portion of thehousing,

said groove being substantially adjacent the forward end of said adapterwhereby manual separation of the forward portion is facilitated,

said flexible tube projecting radially beyond the intermediate portionof said adapter and defining a shoulder there-at,

said housing rear portion having a rear, internal shoulder mechanicallyintergaging the rear shoulder defined by the edge of said flexible tube.4

6. The structure as claimed in Claim 5 in which said adapter has aninternal bore diverging rearwardly from the rear end of said cannula.

7. The structure as claimed in Claim 5 in which said housing forwardportion includes an internal bore terminating rearwardly at saidfrangible connection and being sealingly circumposed about said cannulaimmediately to the rear of the sharpened forward end of the cannula,said internal bore diverging rearwardly from the seal to said frangibleconnection of said housing whereby manual twisting of the forwardhousing portion relative to the rear portion of the housing isfacilitated and separation of the separated parts is promoted.

8. The structure as claimed in Claim 7 in which the rear portion of saidhousing includes opposed, laterally-indented finger grip portions tofacilitate grasping during separation of the housing parts and positivepositioning during introduction of the needle into a patients anatomy.

9. The structure as claimed in Claim 5 in which said adapter comprisesnylon and said flexible tube and housing comprise plasticized polyvinylchloride.

